Calendar

pharmadog

Week of Feb 9, 2026

Feb 9, 2026approval184d agoABSORICA (ISOTRETINOIN) — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: SUN PHARM INDS INC. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Feb 9, 2026approval184d agoISOTRETINOIN — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Feb 9, 2026approval184d agoAMNESTEEM (ISOTRETINOIN) — FDA approvalMylan Pharmaceuticals Inc

Sponsor: MYLAN PHARMS INC. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Feb 9, 2026approval184d agoTRAZODONE HYDROCHLORIDE — FDA approvalTRAZODONE HYDROCHLORIDE

Sponsor: APOTEX INC. Form: TABLET. Route: ORAL

full page →TRAZODONE HYDROCHLORIDE →fda approvals ↗

Feb 9, 2026approval184d agoMETHAZOLAMIDE — FDA approvalMETHAZOLAMIDE

Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL

full page →METHAZOLAMIDE →fda approvals ↗

Feb 9, 2026approval184d agoREGLAN (METOCLOPRAMIDE HYDROCHLORIDE) — FDA approvalmetoclopramide hydrochloride

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →metoclopramide hydrochloride →fda approvals ↗

Feb 9, 2026approval184d agoCLARAVIS (ISOTRETINOIN) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Feb 9, 2026approval184d agoISOTRETINOIN — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Feb 9, 2026approval184d agoABSORICA LD (ISOTRETINOIN) — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: SUN PHARM. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Feb 9, 2026approval184d agoTRAZODONE HYDROCHLORIDE — FDA approvalTRAZODONE HYDROCHLORIDE

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →TRAZODONE HYDROCHLORIDE →fda approvals ↗

Feb 9, 2026approval184d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: UPSHER SMITH LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Feb 9, 2026approval184d agoSCOPOLAMINE — FDA approvalscopolamine ER

Sponsor: RICONPHARMA LLC. Form: SYSTEM. Route: TRANSDERMAL

full page →scopolamine ER →fda approvals ↗

Feb 9, 2026approval184d agoSCOPOLAMINE — FDA approvalscopolamine ER

Sponsor: RICONPHARMA LLC. Form: SYSTEM. Route: TRANSDERMAL

full page →scopolamine ER →fda approvals ↗

Feb 9, 2026approval184d agoSCOPOLAMINE — FDA approvalscopolamine ER

Sponsor: RICONPHARMA LLC. Form: SYSTEM. Route: TRANSDERMAL

full page →scopolamine ER →fda approvals ↗

Feb 9, 2026approval184d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: AMNEAL PHARMS NY. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Feb 9, 2026approval184d agoISOTRETINOIN — FDA approvalISOTRETINOIN

Sponsor: AUROBINDO PHARMA. Form: CAPSULE. Route: ORAL

full page →ISOTRETINOIN →fda approvals ↗

Feb 9, 2026approval184d agoZENATANE (ISOTRETINOIN) — FDA approvalISOTRETINOIN

Sponsor: DR REDDYS LABS LTD. Form: CAPSULE. Route: ORAL

full page →ISOTRETINOIN →fda approvals ↗

Feb 9, 2026approval184d agoLIDOCAINE — FDA approvalLIDOCAINE

Sponsor: USPHARMA. Form: PATCH. Route: TOPICAL

full page →LIDOCAINE →fda approvals ↗

Feb 9, 2026approval184d agoDIGOXIN — FDA approvalDIGOXIN

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →DIGOXIN →fda approvals ↗

Feb 9, 2026device 510k184d agoVascuTech Medical, LLC — Peel-Away Introducer Sheath (510k cleared)

Product code: DYB. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗

Feb 9, 2026device 510k184d agoEdan Instruments, Inc. — Holter ECG and ABP system (HolterABP) (510k cleared)VEECO INSTRUMENTS INC

Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗

Feb 9, 2026device 510k184d agoCeribell, Inc. — Ceribell Instant EEG Headset (510k cleared)Ceribell, Inc.

Product code: GXY. Advisory committee: Neurology. Type: Abbreviated

full page →fda device 510k ↗

Feb 9, 2026device pma184d agoExact Sciences Corporation — Cologuard Plus (PMA supplement)

Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: PA. Decision: OK30

full page →fda device pma ↗

Feb 9, 2026device pma184d agoMedtronic Vascular, Inc. — EverFlex Self-Expanding Peripheral Stent System; EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syste (PMA supplement)

Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Feb 9, 2026device recall184d agoReflexion Medical, Inc. device recall (Cls II)

RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00 — Reason: Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose. — Status: Ongoing

full page →fda device recalls ↗

Feb 9, 2026device recall184d agoAbbott Diagnostics Scarborough, Inc. device recall (Cls II)

Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable — Reason: It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use. — Status: Ongoing

full page →fda device recalls ↗

Feb 9, 2026grant184d agoINDIANA UNIVERSITY INDIANAPOLIS — Mechanisms driving reactivated toxoplasmosis in HIV/AIDS co-infection

AI grant. $384,939. PI: Michael James Holmes

Week of Feb 9, 2026